Kornimate/medical-research-clean huggingface dataset:
twice-daily oral direct thrombin inhibitor dabigatran etexilate in the long term prevention of recurrent symptomatic vte

Conditions: Venous Thromboembolism

Summary: the primary efficacy objective is to evaluate whether dabigatran etexilate is superior to placebo in the long-term prevention of recurrent symptomatic venous thrombo-embolism (vte) in patients with symptomatic deep-vein thrombosis (dvt) or pulmonary embolism (pe) who completed 6 to 18 months of treatment with vitamin k antagonist (vka).


Eligibility criteria:
inclusion criteria: 1. patients with confirmed symptomatic pe or proximal dvt of the leg(s) who have been treated for 6 to 18 months with therapeutic dosages (intended inr between 2-3) of an oral vka (e.g. warfarin, acenocoumarol, phenprocoumon, or fluindione) or re-cover study medication up to the moment of screening for the current study. 2. written informed consent exclusion criteria: 1. younger then 18 years of age 2. indication for vka other than dvt and/or pe 3. patients in whom anticoagulant treatment for their index pe or dvt should be continued 4. active liver disease or liver disease decreasing survival (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or alat \> 3 x uln 5. creatinine clearance \< 30 ml/min 6. acute bacterial endocarditis 7. active bleeding or high risk for bleeding. 8. uncontrolled hypertension (investigators judgement) 9. intake of another experimental drug within the 30 days prior to randomization into the study 10. life expectancy \<6 months 11. childbearing potential without proper contraceptive measures\*, pregnancy or breast feeding
pharmacokinetics of leritrelvir(ray1216) in participants with hepatic impairment

Conditions: Hepatic Impairment

Summary: this study will assess the effect of hepatic impairment on the pharmacokinetics (pk), safety and tolerability of leritrelvir(ray1216)


Eligibility criteria:
inclusion criteria: 1. participant must be ≥ 18 to ≤ 70 years, at the time of signing the informed consent. bmi ≥ 18 kg/m2 up to ≤ 32 kg/m2. 2. participants (including partners) must use reliable methods of contraception during the study and until 7 days following the last dose of investigational product. 3. signature of a dated informed consent form (icf) indicating that the participates has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment. participants with hepatic impairment only: 4. supporting documents confirming that the participant has liver cirrhosis with hepatic impairment must be available. 5. unless otherwise stated, participants must have been on stable doses and regimens of the concomitant medication for at least 4 weeks before screening, or treatment-naïve participants exclusion criteria: 1. participants with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product. 2. qtcf (male) \> 470ms，qtcf (female) \> 480ms 3. participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks 4. participates who donated blood or bleeding profusely (\> 400 ml) in the 3 months. 5. pregnant or lactating women, or women of childbearing age with a positive pregnancy test 6. smoking averaged more than 10 cigarettes per day in the 3 months prior to screening participants with normal hepatic function only: 7. any history of hepatic impairment, or potential presence of liver function impairment by physical examination and laboratory examination at screening. participants with hepatic impairment only: 8. any history of clinically serious illness or disease or condition except for primary liver disease that the investigator believes may affect the results of the trial, including but not limited to a history of circulatory, endocrine, nervous, digestive, urinary, respiratory or hematological, immune, psychiatric, and metabolic disorders. 9. participants with drug-induced liver injury; history of liver transplantation; cirrhosis in combination with the following complications: including but not limited to liver failure, hepatic encephalopathy, hepatocellular carcinoma, esophageal bleeding from ruptured fundic varices
the possible effect of amniotic fluid ph on neonatal morbidities in maternal inflammation/infection associated pregnancies

Conditions: Respiratory Distress Syndrome; Transient Tachypnea of Newborn; Intrauterine Growth Retardation

Summary: amniotic fluid (af) ph can be affected by the maternal and/or fetal conditions such as pprom, prematurity or fetal distress. it is known that fetal urine is the major content of af since 20th gestational week. besides fetal alveolar fluid (faf), gastrointestinal tract, umbilical cord and fetal side of placenta are important sources for af. bombesin-like peptides, 8-hydroxydeoxyguanosine in fetal urine and leukotriene e(4), lecithin, sphingomyelin, lamellar body in faf are molecules acting on fetal lung maturation. varying levels of these molecules relevant to the stage of lung maturation may constitute an association to af phto detect the possible effect of af ph on neonatal respiratory morbidities 1 milliliters of af is aspirated during c-section before incision of membranes. ph value of afs were analyzed by the blood gas machine (siemens rapidlab®1200 systems) of nicu. maternal and neonatal demographic features and clinical outcomes, incidences of morbidities such as respiratory distress syndrome (rds), transient tachypnea of the newborn (ttn) are all recorded.


Eligibility criteria:
inclusion criteria: inflammation/infection associated pregnancies normal healthy pregnancies exclusion criteria: congenital abnormalities chromosomal abnormalities blood contaminated amniotic fluid
expanded access for loxo-260 in participants with cancer caused by an abnormal ret gene that did not respond/is no longer responding to treatment with a type of drug called a ret inhibitor

Conditions: Carcinoma, Non-Small-Cell Lung; Thyroid Neoplasms

Summary: expanded access for participants with cancer caused by an abnormal ret gene that did not respond/is no longer responding to treatment with a type of drug called a ret inhibitor. the treating physician/investigator contacts loxo oncology, inc. when, based on their medical opinion, a patient meets the criteria for expanded access.


Eligibility criteria:
inclusion criteria: * diagnosis of cancer with ret mutant (medullary thyroid cancer \[mtc\] or multiple endocrine neoplasia type 2 \[men2\] tumors) or ret fusion (solid tumors) advanced/metastatic tumors that have become refractory to ret selective tyrosine kinase inhibitor (tki) treatment, who are not eligible or able to participate in an ongoing loxo-260 clinical trial and are medically suitable for treatment with loxo-260. * patients tumor must have developed ret solvent front mutations (eg g810x) after ret selective treatment. * have progressed or are intolerant to standard therapy, or no standard therapy option exists, or in the opinion of the investigator, are unlikely to derive significant clinical benefit from standard therapy * have adequate organ function * patients must reside in a country where the loxo-ngr-21001 study (nct05241834) is not open or recruiting. exclusion criteria: * currently enrolled in an ongoing clinical study of loxo-260 or another second generation ret inhibitor * clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to study treatment; ongoing cardiomyopathy; or current prolongation of the qt interval corrected for heart rate using fridericia's formula (qtcf) interval greater than 470 milliseconds * clinically significant malabsorption syndrome * pregnant or lactating * eastern cooperative oncology group (ecog) performance status 3 or 4 * patients harboring known activating bypass alterations outside ret (eg. egfr, alk, ras etc) that may confer resistance to loxo-260

Keywords: solid tumors
telemonitoring of patients admitted in hospital at home with acute decompensated heart failure - pilot study

Conditions: Heart Failure; With Decompensation; Heart Failure，Congestive; Heart Failure Acute

Summary: "la casa nel parco" (canp) project is a multidisciplinary project funded by the european union and regione piemonte aimed to explore innovative technology application in the care of older subjects. in this context, monterosa is a monocentric randomized controlled open-label clinical trial evaluating the use of a telemonitoring/telemedicine (tm) suite (including a sphygmomanometer, pulse oximeter, weight scale, thermometer, glucometer, electrocardiograph) as a support to the routine clinical care of patients admitted to a hospital at home service for acute decompensated heart failure. the main objective of the study will be to evaluate the impact of tm on number of daily physician's visits. secondary objectives will be to evaluate the impact of tm on number of daily nurse visits, on overall in-hospital mortality and on patient's and caregiver's quality of life.


Eligibility criteria:
inclusion criteria: * patient admitted in hospital at home with signs and/or symptoms of new-onset or decompensated heart failure, according with the definition of 2016 european society of cardiology (esc) guidelines on heart failure * written informed consent signed by both the patient and the main caregiver exclusion criteria: * main caregiver with low it skills (e.g. unable to use a smartphone); * patient in whom body weight or accurate daily urine output cannot be measured * patient with history of neoplastic/degenerative disease and with estimated life expectancy less than 3 months * patient with decompensated liver cirrhosis (child-pugh score b o c)

Keywords: telemedicine telemonitoring hospital at home home hospitalization
sleeve gastrectomy versus gastric bypass for private pay patients seeking obesity surgery

Conditions: Morbid Obesity

Summary: the purpose of this study is to determine laparoscopic sleeve gastrectomy is a safer surgery than the gastric bypass, gives similar weight losses and that the safety of gastric in private pay patients versus insurance patients will be similar. this is a retrospective chart review of intervention charts.

this study is a retrospective chart review of 800 intervention charts each for consecutive laparoscopic sleeve gastrectomies compared to consecutive laparoscopic gastric bypasses performed by two surgeons in a louisiana private practice. this retrospective chart review will evaluate the safety of the two procedures during the operative and 6-week post-operative periods, compare the insurance patients to the private pay patients having the gastric bypass, and comparative weight loss in subjects with a follow-up of at least 18 months. this offers the unique opportunity to compare any differences in surgical complications in subjects paying by insurance versus those paying personally for the gastric bypass operation.

Eligibility criteria:
inclusion criteria: * the last 800 consecutive patients in the surgical practice of drake bellanger and andrew hargroder who had a laparoscopic sleeve gastrectomy. * the last 800 consecutive patients in the surgical practice of drake bellanger and andrew hargroder who had a laparoscopic gastric bypass. exclusion criteria: * subjects having any other obesity surgical procedure

Keywords: laparoscopic sleeve gastrectomy laparoscopic gastric bypass
a trial to measure the difference in all-cause hospitalizations for participants who are using abilify mycite versus virtual matched controls in adults with schizophrenia, bipolar 1 disorder, and major depressive disorder

Conditions: Schizophrenia; Bipolar 1 Disorder; Major Depressive Disorder

Summary: the primary objective of this pragmatic clinical trial (main study) was to assess the difference between all-cause hospitalizations in participants using abilify mycite versus virtual matched controls. in addition, secondary and exploratory objectives were to assess medication adherence, healthcare utilization and costs, and patient-reported outcomes.

this was a phase 4, open-label, prospective, pragmatic clinical trial to assess the difference between all-cause hospitalizations in participants using abilify mycite (for months 1-3, then prohibited for months 4-6) versus virtual matched controls from baseline to day 180. virtual matched controls were to receive treatment as usual (that is, any product other than abilify mycite, which was oral aripiprazole or any other product). eligible participants entered a screening period of up to 13 days. for participants enrolling into the study, those not on aripiprazole at screening used the screening period for conversion to aripiprazole from other antipsychotics. virtual matched controls were not to be enrolled into the study, but identified from health insurance claims data and matched to the enrolled abilify mycite participants at the end of the study for analysis. after the visit at day 180, a second, optional interventional period (up to 6 months of abilify mycite) could have been initiated per the joint decision of the participants with their study physician; participants in this second, optional interventional period were to have a visit at day 360. during this second, optional interventional period, participants may have started and stopped abilify mycite as clinically indicated. a parallel exploratory study that would utilize a different set of physicians and participants from the main study was planned; however, that study was never initiated.

Eligibility criteria:
inclusion criteria: * participants are actively enrolled in an anthem-affiliated commercial, medicaid, or medicare health plan with medical and pharmacy benefits. * participants must have a smartphone with data plan. * participants currently prescribed aripiprazole, or appropriate for aripiprazole treatment. * participants must have a current diagnosis of sch, bp1, or mdd. exclusion criteria: * any participant who participated in another clinical trial within 30 days of enrollment into the current study. * females who are breast-feeding and/or who are pregnant at the time of study enrollment, or who plan to become pregnant during the study. * participants who are currently being treated with a long-acting injectable antipsychotic.

Keywords: digital medicine system
evaluation of the effect of preoperative symbiotic bowel conditioning on surgical site infection after elective colorectal surgery

Conditions: Postoperative Wound Infection

Summary: the objective of the study is to investigate whether peri-operative symbiotic treatment could reduce the risk of postoperative infections in patients undergoing elective colorectal surgery. this study was also designed to assess the risk-adjusted incidence and predictors of surgical site infections.


Eligibility criteria:
inclusion criteria: 1. both genders 2. more than 14 years old 3. candidate for elective colorectal surgery exclusion criteria: 1. denied written informed consent, 2. severe neutropenia, and 3. critically ill condition 4. not meeting inclusion criteria

Keywords: colorectal surgery surgical site infection symbiotic
functional limitation, pain and quality of life in patients with cervical spondylotic radiculopathy

Conditions: Radiculopathy; Elderly

Summary: radiculopathy is a neurological condition in which transmission along a spinal nerve and its roots is limited or inhibited. it is most caused by spondylotic changes such as cervical disc herniation leading to nerve root compression, inflammatory changes, and the formation of bony prominences in this region \[1\]. pain is the initial symptom and cervical radiculopathy should be suspected when pain radiates from the neck to the shoulder and arm, accompanied by sensory complaints and motor weakness. it is most commonly caused by spondylotic changes, such as cervical disc herniation and bony prominences in this area, leading to nerve root compression and inflammatory changes. stenotic changes in the spine, which are often observed with aging, can cause nerve damage and compression in individuals, causing radicular pain. however, there is insufficient study in which the relationship between pain caused by cervical spondylotic radiculopathy caused by stenosis and functional disability, disability and quality of life due to radiculopathy in patients is insufficient. in addition, the lack of a comprehensive outcome scale that evaluates the functional limitation caused by radicular pain has also led to a deficiency in the evaluation of functional limitation. in this context, cres is a newly developed scale used to evaluate functional limitation associated with radicular pain. in this context, in this study, it was aimed to examine the relationship between pain, functional disability, disability and quality of life in patients with cervical spondylotic radiculopathy.


Eligibility criteria:
inclusion criteria: * over 18 years of age * with lateral-foraminal spinal stenosis in the cervical region * with or without neck pain consistent with the diagnosis obtained from magnetic resonance imaging * with unilateral root symptoms such as pain, numbness, weakness in the affected limb, and diagnosis based on mri and computerized tomography exclusion criteria: * signs of increased ventral pressure, such as ventral osteophytes, disc calcification, and ligament hypertrophy * severe neurological deficits, pregnant women, spinal malignancies, * those who had undergone cervical surgery in the last 12 months * and those who could not cooperate
probiotics in pulmonaty rehabilitation for copd

Conditions: COPD (Chronic Obstructive Pulmonary Disease); Probiotic Intervention; Body Composition Measurement

Summary: this study aims to investigate various aspects of patients with chronic respiratory diseases undergoing pulmonary rehabilitation supplemented with probiotics. the focus will be on clinical physiological responses, functional performance, respiratory status assessments, nutritional status evaluations, body composition analyses, and biochemical blood parameters, with a primary emphasis on the anti-inflammatory response.

background： patients with chronic obstructive pulmonary disease (copd) often suffer from malnutrition and weight loss, which negatively impact mortality rates. research indicates that insufficient intake of fiber, vitamins, and folic acid is associated with airflow limitation in copd. malnutrition affects lung function and muscle strength, leading to difficulty in breathing and reduced exercise tolerance. nutritional support interventions, such as probiotics, are valuable in improving the nutritional status, lung function, and pulmonary rehabilitation in copd patients. study design： this is a one-year, single-center, prospective randomized controlled trial. methods： this study is a randomized controlled trial targeting copd patients undergoing pulmonary rehabilitation. the plan is to recruit 60 participants, randomly assigned to either the probiotic intervention group or the conventional pulmonary rehabilitation group. the study includes physiological parameters, functional tests, questionnaires, and blood biochemical analyses. data will be analyzed using spss, with statistical significance set at p \< 0.05. effect： the trial expects that copd patients receiving probiotic supplementation will achieve significant muscle gain and fat loss, reduce inflammation, and exhibit changes in body composition and functional performance. key words： chronic obstructive pulmonary disease; probiotics; nutritional supplementation; inflammation markers; body composition

Eligibility criteria:
inclusion criteria: * willing to sign a written informed consent form. * diagnosed with pre-copd or copd stage i-iv according to the 2023 gold guidelines. * undergoing pulmonary rehabilitation therapy for more than three months. exclusion criteria: * under 18 years old. * diagnosed with neuromuscular diseases. * experienced respiratory disease exacerbation requiring emergency care or hospitalization in the past three months. * unable to cooperate with cardiopulmonary exercise testing. * has other diseases or behavioral restrictions preventing participation in exercise training for over one year. * assessed by a physician to have severe malnutrition or a significantly low bmi.

Keywords: body composition inflammation markers nutritional supplementation probiotics chronic obstructive pulmonary disease
lactate acidosis in postoperative hearts

Conditions: Post-cardiac Surgery; Hyperlactatemia

Summary: this is a single-center, observational study. investigators aim to characterize the metabolism of lactate in children over the first forty-eight hours following cardiac surgery. blood samples will be obtained up to 12 timepoints. samples will be analyzed for concentration of pyruvate. results will be compared to standard of care laboratory results for lactate and other direct and indirect measures of cardiac output.

investigators will characterize the etiologies of hyperlactatemia predominantly present at serial postoperative timepoints in children recovering from cardiac surgery by following lactate levels and the lactate-to-pyruvate ratio over the first 48 post-operative hours and correlating them with cardiac output as determined by conventional markers and physical exam. investigators expect to validate the assumption that in children recovering from heart surgery whose cardiac output is apparently normal, hyperlactatemia (if seen) is predominantly due to impaired lactate clearance or metabolism, while in those whose cardiac output is low, it is predominantly due to inadequate oxygen delivery. blood samples will be obtained up to 12 timepoints (arrival at the intensive care unit postoperatively, hour 1, hour 2, hour 3, hour 4, hour 6, hour 8, hour 10, hour 12, hour 24, hour 36 and hour 48 postoperative) or only at up to 6 time points (approximately hour 0, 2, 4, 6, 8, and 12) for infants under 10 kg as described below. . samples will be analyzed for concentration of pyruvate. results will be compared to standard of care laboratory results for lactate and other direct and indirect measures of cardiac output.

Eligibility criteria:
inclusion criteria: * all immediately post-operative cardiac patients admitted to the pediatric cardiac intensive care unit (pcicu) exclusion criteria: * lack of parental or patient consent, or patient assent when applicable, including non-english speakers and wards of the state * dosing weight less than 4 kg\* * cardiac catheterization being the only operative procedure * severe hepatic dysfunction at any time during the hospital course * seizures during the study period * sepsis during the study period * need for extracorporeal membrane oxygenation or continuous renal replacement therapy * known congenital myopathy, ataxia, polyneuropathies or inborn errors of metabolism including congenital lactic acidosis and other mitochondrial disorders * primary hypoventilation * malignancies * fanconi syndrome * wernicke encephalopathy

Keywords: pediatric congenital heart disease
pilot study of 89-zr panitumumab in pancreas cancer

Conditions: Pancreas Cancer

Summary: the main purpose of the study is to assess the safety of 89zr-panitumumab as a molecular imaging agent in patients with (metastatic) pancreas cancer.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of pancreatic cancer. exclusion criteria: * myocardial infarction (mi); cerebrovascular accident (cva); uncontrolled congestive heart failure (chf); significant liver disease; or unstable angina within 6 months prior to enrollment. * history of infusion reactions to monoclonal antibody therapies. * pregnant or breastfeeding. * subjects receiving class ia (quinidine, procainamide) or class iii (dofetilide, amiodarone, sotalol) antiarrhythmic agents. * subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis. * severe renal disease or anuria. * known hypersensitivity to deferoxamine or any of its components.